This is a Phase 3, randomized, double-blind, placebo-controlled, efficacy and safety study of subjects with IPF treated with inhaled treprostinil over a 52-week period. This study is investigating whether a drug called inhaled treprostinil (brand name Tyvaso®) works to help people with IPF improve their lung function tests. The purpose of this research study is to see how well inhaled treprostinil works in participants with IPF and to gather information on how safe it is. This study will look at changes in your breathing tests, also called lung function tests. About 396 people will participate in this study from about 100 medical centers. Your participation in this study is voluntary and will last approximately 58 weeks. This time includes a Screening Period that could last up to approximately 6 weeks plus a 52-week Treatment Period.
This study is for patients that have been diagnosed with multiple myeloma. The usual approach for patients with newly diagnosed multiple myeloma who are not in a study, is lenalidomide and dexamethasone in combination with bortezomib or daratumumab. This approach is approved by the Food and Drug Administration (FDA). The purpose of this study is to see if patients who have a small amount of cancer left after initial treatment (called minimal residual disease (MRD)), could benefit from adding a new drug to the usual treatment. The study approach, using a combination of four drugs, is investigational and not approved by the FDA. Patients can expect to be on this study for up to 2 years. Patients will then be followed by their doctor for up to 15 years after completion of the study or until disease progression..
This study is for patients with newly diagnosed diffuse Large B Cell Lymphoma.
This study will help the study doctors find out if taking R-mini-CHOP plus the study drug CC-486 (oral azacitidine) is better, the same, or worse than taking the R-mini-CHOP drug combination alone. To decide if it is better, the study doctors will be comparing the drug combinations to see which drug combination allows more patients to have no disease symptoms at 1 year or more after the start of the study treatment and which drug combination extends the overall survival (how long people live) of patients at 5 years after the start of the study treatment.
This study is for patients with advanced kidney cancer and the purpose is to see if by adding a drug called cabozantinib to another treatment after receiving the standard treatment can prolong their life.
Alcohol use disorder (AUD) and intoxication have been shown to lead to episodes of intimate partner violence (IPV). Approximately one third of U.S. adults experience IPV during their lifetimes. Research shows that IPV has negative effects on treatment for AUD treatment and increases risk of relapse. Although treatments targeting AUD and IPV do work for some people, we often see high dropout rates, and resistance to change.
This project seeks to develop interactive treatment options to successfully reduce AUD and IPV concurrently. The purpose of the study is to examine the usability, feasibility, and acceptability of wearable activity trackers (like a smart watch) and use of a cell phone application (app) among couples. We are also testing the use of this device and app will affect alcohol use and couple conflict.
This study involves a screening phase and a 28 observation period where participants are asked to wear a smart watch, complete assessments and provide feedback.
This study is for patients who have cancer and are experiencing loss of weight and appetite. The study wants to find out if this taking olanzapine for four weeks will increase your appetite as compared to megestrol acetate. The study is looking to see if that approach is better or worse than the usual approach for your loss of appetite and weight. The usual approach is defined as care most people get for loss of appetite.
This research study is enrolling participants that have been diagnosed with advanced gastric cancer (a disease in which cancer cells form in the lining of the stomach) or gastroesophageal junction cancer (a type of cancer forming in the area where the tube that connects the mouth and the stomach join together) and have not received prior treatment for advanced cancer and the tumor has already tested positive for fibroblast growth factor receptor 2b (FGFR2b) expression. FGFR2b is a protein that possibly causes cells to grow more quickly and multiply abnormally. The purpose of this study is to see if bemarituzumab is safe, tolerable, and effective when administered along with mFOLFOX6 (a combination of 5 fluorouracil [5 FU], oxaliplatin and leucovorin) and nivolumab and whether it causes any side effects. Bemarituzumab is not approved by the Food and Drug Administration (FDA). Participants will be pre-screening to see if they qualify to participate in Part 2. During the pre-screening portion, participants will provide either archived tissue or a fresh tumor sample in order to test for FGFR2b proteins. If the test results show an excessive amount of FGFR2b proteins in the tumor, participants may be asked to consider participating in the Part 2 study involving bemarituzumab, an investigational drug for people with advanced gastric or gastroesophageal junction cancer. Participants in this study will receive either bemarituzumab with mFOLFOX6 and nivolumab or placebo with mFOLFOX6 and nivolumab. The placebo will look like bemarituzumab but it will not contain active ingredients and has no effect on participants' condition. This study involves pharmacokinetic testing which is a blood test to determine how much study drug is in the blood. Bemarituzumab is not approved by the Food and Drug Administration (FDA). Participants could be in this study for up to 40 months and up to 57 visits.
This study is for newly diagnosed or previously untreated low-grade glioma (LGG). The overall goal of this study is to see if selumetinib works just as well as the standard treatment using carboplatin and vincristine (called CV) for subjects with LGG. Selumetinib is a drug that works by blocking a protein (a basic building block of the human body) that lets cancer cells grow without stopping. Participants can expect to receive treatment on this study for about 1–2 years. After study completion, participants will continue to be followed for up to 10 years.
This study is for patients that have been diagnosed with non-germinomatous germ cell tumor (NGGCT). The goal of this study is to see if radiation therapy (RT) to the spine and a portion of the brain works just as well as the standard treatment, which includes RT to the whole brain and spine, for people with NGGCT who agree to take part in this study, and whose disease responds well to induction chemotherapy, or who have no signs of disease following surgery. Participants can expect to receive treatment on this study for about 6 to 11 months, depending on which therapy they receive. After study completion, participants will continue to be followed for up to 10 years.
This study is for newly diagnosed previously untreated neurofibromatosis type 1 (NF1) associated with low-grade glioma (LGG). The purpose of this study is to see if selumetinib works just as well as the standard treatment of carboplatin/vincristine (CV) for subjects with NF1-associated LGG, and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway. Participants can expect to receive treatment for up to 24 months, until the cancer gets worse or until the side effects are too great. After study completion, participants will continue to be followed for up to 10 years.